Multiple SclerosisNCT06056960
Preventing the Progression of Multiple Sclerosis: Early Rehabilitative Treatment and Multimodal Assessment - Part B
A study testing Tailored Physical Activity in people with Multiple Sclerosis, run by Fondazione Don Carlo Gnocchi ETS at 3 sites in Italy.
Trial summary
It is widely recognized that physical exercise is safe and people with moderate Multiple Sclerosis (MS) are encouraged to train regularly to improve their skills in motor task execution. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Tailored Physical Activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 3 sitesItaly
- Study dates
- 15 Jul 2024to 30 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 17 years
- Stable disease course (without worsening over 1 point at the Expanded Disability Status Scale in the last 3 months)
Who cannot join
- Major depression
- Mini-Mental State Examination < 27
- Other cardiovascular or orthopedic diseases that interfere with physical exercise
- Progressive course of the disease
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
Ospedale Binaghi ASL Cagliari
Cagliari
IRCCS Ospedale San Raffele
Milan, 20100
IRCCS Fondazione Don Carlo Gnocchi
Milan, 20148
About this study
Official title: Preventing the Progression of Physical Disability and Promoting Brain Functional Adaptation in People With Multiple Sclerosis: Integration of Early Rehabilitative Treatment and Multimodal Clinical and Instrumental Assessment - Part B
It is widely recognized that physical exercise is safe and people with moderate Multiple Sclerosis (MS) are encouraged to train regularly to improve their skills in motor task execution. Several studies demonstrated that these activities represent an effective low-cost therapy which leads to significant and clinically meaningful improvements in gait and balance in people with MS (PwMS) with mild to moderate walking dysfunction, possibly also by promoting brain plasticity.
There is general agreement within the scientific community on the importance of timing intervention also during the early stages of MS to preserve or improve walking and balance abilities and fostering brain functional adaptation, thus slowing down the disease progression. Previous studies highlighted the need to early identify and manage gait disorders using a multimodal approach tailored on individual's need. Moreover, Functional Near-Infrared Spectroscopy (fNIRS) measures blood flow which accompanies neuronal activity and thus, it can provide spatial information about changes in cortical activation patterns due to the possible effects of exercise on cortical plasticity.
To the best of the investigators knowledge, no published studies have assessed the effect of exercise on mobility and brain activity in PwMS with minimal or clinically undetectable disability. This emphasizes the need of trials investigating the effect of walking exercise as preventive strategy on MS clinical worsening.
- Conditions
- Multiple Sclerosis
- Being tested
- Tailored Physical Activity
- Keywords
- early phase, non-disabled
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored Physical ActivityOther
The intervention will comprise 16 sessions (2 sessions/week). 30 minutes of walking training wearing a heart rate (HR) monitor to keep exercise intensity below 70% of maximal HR.
Right after, 30 minutes of balance exercises will be performed. An experienced physical therapist will tailor exercises. Subjects will be taught how to perform the exercises by themselves. A booklet will be provided to provide guidelines. A physical therapist will call subjects, every training day to check for any problem.
| Study group | Role | What they receive |
|---|---|---|
| Physical Activity | Experimental | The experimental group will perform a combination of endurance and balance training tailored to the subject. Receives: Other: Tailored Physical Activity |
| Usual Activity | No intervention | The control group will perform their usual daily activities. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue Severity Scale (FSS)
Is a 9-item self-administered questionnaire to measure the perceived impact of fatigue. The minimum score is 9 and maximum score possible is 63. Higher scores represent greater fatigue severity. If the score is calculated as the mean score of the 9 items, the cut-off score for the presence of the symptom fatigue is set as scores higher than 4.
Measured: Baseline, Post, FollowUp_6month
Secondary outcomes (4)
Differences in oxygenated hemoglobin (Delta oxyHb)
The differences in oxyHb during task period and resting state. Data will be extracted from functional Near InfraRed Spectroscopy (fNIRS) assessment.
Measured: Baseline, Post, FollowUp_6month
Six Minute walking test (6MWT)
Gait asymmetry and regularity extracted from Inertial Measurement Unit's during the six minute walking test.
Measured: Baseline, Post, FollowUp_6month
Number of steps/day
Assessed by activity trackers, a non-invasive method of monitoring human rest/activity cycles. Subjects will be monitored for 1 week wearing an actigraph.
Measured: Baseline, Post, FollowUp_6month
Endurance walking capacity
Assessed as the distance walked over 6 minutes as a sub-maximal test of endurance (6MWT).
Measured: Baseline, Post, FollowUp_6month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start15 Jul 2024 (estimated)
- Primary completion30 Jan 2025 (estimated)
- Study completion30 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Collaborators
- IRCCS San Raffaele, Azienda Sanitaria Locale di Cagliari
- Responsible party
- Sponsor
- Investigators
- Marco Rovaris, MD, Principal investigator, IRCCS Fondazione Don Carlo GnocchiRaffaella Chieffo, MD, Principal investigator, IRCCS Ospedale San RaffaeleEleonora Cocco, MD, Principal investigator, Ospedale Binaghi ASL Cagliari, Sardegna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06056960
- Sponsor's protocol ID
- 03_17/02/2021 Part B
- Status last verified
- Jul 2023
- First submitted
- 11 Sep 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing the Progression of Physical Disability and Promoting Brain Functional Adaptation in People With Multiple Sclerosis: Integration of Early Rehabilitative Treatment and Multimodal Clinical and Instrumental Assessment - Part B
- ClinicalTrials.gov ID
- NCT06056960
- Acronym / sponsor ID
- 03_17/02/2021 Part B
- Conditions
- Multiple Sclerosis
- Keywords
- early phase, non-disabled
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Collaborators
- IRCCS San Raffaele, Azienda Sanitaria Locale di Cagliari
- Study start
- 15 Jul 2024 (estimated)
- Primary completion
- 30 Jan 2025 (estimated)
- Study completion
- 30 Jan 2025 (estimated)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is widely recognized that physical exercise is safe and people with moderate Multiple Sclerosis (MS) are encouraged to train regularly to improve their skills in motor task execution. Several studies demonstrated that these activities represent an effective low-cost therapy which leads to significant and clinically meaningful improvements in gait and balance in people with MS (PwMS) with mild to moderate walking dysfunction, possibly also by promoting brain plasticity.
There is general agreement within the scientific community on the importance of timing intervention also during the early stages of MS to preserve or improve walking and balance abilities and fostering brain functional adaptation, thus slowing down the disease progression. Previous studies highlighted the need to early identify and manage gait disorders using a multimodal approach tailored on individual's need. Moreover, Functional Near-Infrared Spectroscopy (fNIRS) measures blood flow which accompanies neuronal activity and thus, it can provide spatial information about changes in cortical activation patterns due to the possible effects of exercise on cortical plasticity.
To the best of the investigators knowledge, no published studies have assessed the effect of exercise on mobility and brain activity in PwMS with minimal or clinically undetectable disability. This emphasizes the need of trials investigating the effect of walking exercise as preventive strategy on MS clinical worsening.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Activity | Experimental | Other: Tailored Physical ActivityThe experimental group will perform a combination of endurance and balance training tailored to the subject. |
| Usual Activity | No intervention | –The control group will perform their usual daily activities. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age > 17 years
- Stable disease course (without worsening over 1 point at the Expanded Disability Status Scale in the last 3 months)
Key exclusion criteria (4 listed)
- Major depression
- Mini-Mental State Examination < 27
- Other cardiovascular or orthopedic diseases that interfere with physical exercise
- Progressive course of the disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tailored Physical ActivityThe intervention will comprise 16 sessions (2 sessions/week). 30 minutes of walking training wearing a heart rate (HR) monitor to keep exercise intensity below 70% of maximal HR. Right after, 30 minutes of balance exercises will be performed. An experienced physical therapist will tailor exercises. Subjects will be taught how to perform the exercises by themselves. A booklet will be provided to provide guidelines. A physical therapist will call subjects, every training day to check for any problem. | Other | Physical Activity |
Primary outcome
Fatigue Severity Scale (FSS)
Time frame: Baseline, Post, FollowUp_6month
Is a 9-item self-administered questionnaire to measure the perceived impact of fatigue. The minimum score is 9 and maximum score possible is 63. Higher scores represent greater fatigue severity. If the score is calculated as the mean score of the 9 items, the cut-off score for the presence of the symptom fatigue is set as scores higher than 4.
4 secondary outcomes
Differences in oxygenated hemoglobin (Delta oxyHb)
Time frame: Baseline, Post, FollowUp_6month
Six Minute walking test (6MWT)
Time frame: Baseline, Post, FollowUp_6month
Number of steps/day
Time frame: Baseline, Post, FollowUp_6month
Endurance walking capacity
Time frame: Baseline, Post, FollowUp_6month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco Rovaris, MD principal investigator
IRCCS Fondazione Don Carlo Gnocchi
Raffaella Chieffo, MD principal investigator
IRCCS Ospedale San Raffaele
Eleonora Cocco, MD principal investigator
Ospedale Binaghi ASL Cagliari, Sardegna
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored Physical Activity in people with Multiple Sclerosis, run by Fondazione Don Carlo Gnocchi ETS at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue Severity Scale (FSS) (time frame: Baseline, Post, FollowUp_6month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.